Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2026-01-05 @ 10:54 PM
Study NCT ID:
NCT06739551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-18
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Treatment Options for Generalized Lichen Planus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008010', 'term': 'Lichen Planus'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D017255', 'term': 'Acitretin'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-17', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-17', 'lastUpdatePostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus', 'timeFrame': 'Clinical assessment for efficacy will be done 4 weekly for 12 weeks.', 'description': 'Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 12 th week after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease:\n\n1. Remission: It is defined as complete resolution of all lesions leaving behind normal skin or post inflammatory pigmentation.\n2. Improvement: It is defined as a more than 50% decrease of the disease, as clinically measured by the surface area from the baseline.\n3. No improvement: It is defined as less than a 50% improvement in the disease, as measured clinically by the surface area from the baseline.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lichen Planus', 'Acitretin', 'Methotrexate', 'Efficacy'], 'conditions': ['Lichen Planus']}, 'descriptionModule': {'briefSummary': 'Lichen planus is a chronic inflammatory skin condition with unknown etiology. It requires a long term treatment. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of two familiar drugs (acitretin and methotrexate) in the treatment of generalized lichen planus as to find out the relatively more effective and safer treatment.', 'detailedDescription': 'Lichen planus (LP) is a chronic mucocutaneous condition of an unknown cause. It presents clinically as purple, itchy papules and plaques on the lower back, body folds, oral mucosa, and on the scalp(1). It is recurrent condition with a prolonged course and requires an effective, safer and relatively cheaper treatment option (2).\n\nObjective: "To compare the efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus".\n\nMaterial \\& Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion \\& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 124 patients which will be divided into 2 groups A \\& B, 62 in each group. Group A will receive oral methotrexate 10mg once weekly for 12 weeks. Group B will receive oral acitretin 50mg daily for 12 weeks. Folic acid will be given to all patients in group A at a dose of five milligram per day. Patient will be followed at 4 weekly interval and final efficacy will be determined at 12th week.Data will be analyzed by SPSS v25.0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-60 years\n* Gender: both male and female\n* Type of Lichen planus: generalized lichen planus\n* Patients not taking prior treatment in last 1 month\n\nExclusion Criteria:\n\n* Pregnancy and lactating females\n* Bleeding disorders\n* Abnormal liver function tests\n* Platelet count less than 100000\n* Hypersensitivity to Methotrexate or Acitretin\n* Unrealistic expectations'}, 'identificationModule': {'nctId': 'NCT06739551', 'briefTitle': 'Systemic Treatment Options for Generalized Lichen Planus', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheikh Zayed Medical College'}, 'officialTitle': 'Comparison of Efficacy of Oral Methotrexate and Acitretin for Generalized Lichen Planus', 'orgStudyIdInfo': {'id': 'SheikhZMC/H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral methotrexate group (Group A)', 'description': 'Patients with generalized lichen planus will be given 10 mg per week', 'interventionNames': ['Drug: Methotrexate (drug)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Acitretin group (Group B)', 'description': 'Patients with generalized lichen planus will be given oral acitretin 50 mg once daily', 'interventionNames': ['Drug: Acitretin']}], 'interventions': [{'name': 'Methotrexate (drug)', 'type': 'DRUG', 'description': 'oral methotrexate 10 mg per week for 12 weeks', 'armGroupLabels': ['Oral methotrexate group (Group A)']}, {'name': 'Acitretin', 'type': 'DRUG', 'description': 'oral acitretin 50 mg once daily for 12 weeks', 'armGroupLabels': ['Oral Acitretin group (Group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64200', 'city': 'Rahim Yar Khan', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Sheikh zayed Medical college SZMC/H', 'role': 'CONTACT', 'email': 'info@szmc.edu.pk', 'phone': '+92689230168'}], 'facility': 'Sheikh zayed Medical College and Hospital', 'geoPoint': {'lat': 28.41987, 'lon': 70.30345}}], 'centralContacts': [{'name': 'Mohibullah, Post graduate resident', 'role': 'CONTACT', 'email': 'mohibzahidi.123@gmail.com', 'phone': '+923168716717'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheikh Zayed Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post Graduate Resident in Dermatology', 'investigatorFullName': 'Mohibullah Zahidi', 'investigatorAffiliation': 'Sheikh Zayed Medical College'}}}}